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Completed

NCT Number: NCT05552378

Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms

Women diagnosed with Vulvovaginal Candidiasis by the health care professional will be enrolled in the study. All participants should fulfil inclusion and exclusion criteria.

The study product will be used for 5 days, once a day. The doctor will evaluate the patients before and at the end of the treatment.

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Key information

Conditions

Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Medical Centre

Gdansk, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with Vulvovaginal Candidiasis confirmed by:itching, and/or burning, irritation, edema, redness, crumbly white discharge
  • Aged >18 years
  • Signed written informed consent form
  • Willing to comply to the follow-up schedule
  • Subject affiliated to a health social security system.
  • Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.

Exclusion criteria

  • Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, bacterial vaginosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
  • Current genital malignancies
  • Chemotherapy for any reason in last 6 months
  • Radiotherapy in the genitourinary system in the last 12 months
  • Pregnancy or currently attempting to conceive
  • Lactation
  • Use of other treatment for vaginal conditions during the course of the clinical investigation
  • Known allergies to ingredients of the product
  • Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation

Treatment and study plan

Multi-Gyn FloraFem

Device

Vaginal gel packed in 5 single use plastic tubes.

Primary outcomes

  1. To determine the efficacy of Multi-Gyn FloraFem in relieving itch during vaginal candidiasis (based on 0-10 point scale score improvement > 1 related to vulvovaginal candidiasis at Visit 2.

    Time frame: 1 week

    Women should have at least itch related to vaginal candidiasis.

Sponsors and collaborators

Lead sponsor

Karo Pharma AB

Industry

Registry information

Official study title

A Single Arm Stuidy to Confirm Safety and Efficacy of Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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